TCT-777 Non-Cerebrovascular Systemic Arterial Embolic Events from Paradoxical Embolization via Patent Foramen Ovale (PFO)

Background: Percutaneous closure of ASD/ PFO has become a common procedure. Concerns exist regarding possible adverse outcomes with device implantation in patients allergic to nickel. Quantifying nickel elution by various devices is important. Methods: We compared nickel elution behavior of 4 devicesAGA Amplatzer® Occluder “Cribriform” (AGA Medical Corporation; Plymouth, Minn), Gore GSO® and Gore Helex® Septal Occluder (W.L.Gore & Associates, Flagstaff, AZ), Sternalwire, and control-1xDulbecco’s Phosphate-Buffered Saline (DPBS). Three device samples from each group were submerged in DPBS. Nickel elution was measured by blinded personal using Plasma Mass Spectroscopy at 24hours (h), 48h, 72h then weekly to 60 days. Results: Nickel elution was significantly higher for AGA device compared to control group at all time points to 60 days (15.20 2.89 vs 0.01 0mg/L, p .001,Figure1). Individual group comparisons by Bonferroni Multiple Comparisons test showed that nickel elution was statistically similar amongst devices other than AGA.